D R Burton OxyPAP
K号: K192000 · 2020-02-19
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决定日期2020-02-19
产品代码BWF
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
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器械摘要
D R Burton OxyPAP is the device name listed in this FDA 510(k) record. The listed applicant is D R Burton Healthcare, LLC. It received FDA 510(k) clearance on 2020-02-19 under 510(k) number K192000. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the D R Burton OxyPAP?
D R Burton OxyPAP is a medical device that received FDA 510(k) clearance on 2020-02-19. The listed applicant is D R Burton Healthcare, LLC. The 510(k) number is K192000.
When did D R Burton OxyPAP receive FDA 510(k) clearance?
D R Burton OxyPAP received FDA 510(k) clearance on 2020-02-19, under 510(k) number K192000.
Who is the listed applicant for D R Burton OxyPAP?
The FDA 510(k) record lists D R Burton Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for D R Burton OxyPAP?
The FDA product code for D R Burton OxyPAP is BWF.
相关临床试验
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列明D R Burton Healthcare, LLC为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：BWF）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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